Devices · Biofourmis Singapore Pte. Ltd

Biovitals Analytics Engine

Biofourmis Singapore Pte. Ltd is listed for Biovitals Analytics Engine (K183282). The FDA list gives August 15, 2019 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PLB as “Multivariate Vital Signs Index”: Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183282

Official FDA database record

Date of final decision

August 15, 2019

Company on the FDA list

Biofourmis Singapore Pte. Ltd

Lead panel

Cardiovascular

Primary product code

PLB

openFDA device name for the code

Multivariate Vital Signs Index

Device class

2

Regulation number

870.2300

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary